CLINICAL TRIALS AND RESEARCH

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SCV's Research Ripple and events information

SCV's Research Ripple

Sign up to receive the latest news from SCV's Research, Strategy and Clinical Trials Office. This communication is open to all stakeholders in research and clinical trials sectors.

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Previous editions:
Please note that SCV's Research Ripple has now replaced the Streamline e-Bulletin.

Past Streamline e-Bulletins

Events

National Clinical Trials Governance Framework

Learnings from 2023. 06 February 2024

Learnings from 2023

Australian Teletrial Program-Victoria (ATP-VIC)

Teletrials - Ethics, site governance and startup - 21 July 2023

Past annual May conferences

Annual May conference presentations – 01 May 2019
Streamlining Clinical Trials and Research: 10 Years in Victoria

Annual May conference presentations - 2 May 2018
Research Landscape - Advances and Changes

National mutual acceptance symposium

Contact us

Contact the Research, Strategy and Clinical Trials team:

Email: multisite.ethics@safercare.vic.gov.au
Phone: 0408 274 054 - General enquiries and ERM application advice
Phone: 0408 410 938 - Enquiries and ERM for Research Office administrators

9am – 5pm AET, Monday – Friday

Documents

(MS Word Document - 157.0 KB)

Forms

Ethics Checklist

Pro-forma checklist to assist with preparing an ethics application (MS Word Document - 164.4 KB)

Research Governance Checklist

To assist with preparing a research governance / Site Specific Assessment (SSA) application (MS Word Document - 772.1 KB)

Victorian Specific Module WORD version

For each research project that has a site in Victoria, the Victorian Specific Module (VSM) must be completed and submitted to the reviewing Human Research Ethics Committee (HREC) as part of the ethics application. (MS Word Document - 69.2 KB)

Evaluation of a site as a Satellite Site checklist

(MS Word Document - 160.3 KB)

Primary Site Workflow checklist

(MS Word Document - 158.6 KB)

Evaluation of a trial as a teletrial checklist.docx

(MS Word Document - 157.3 KB)

Teletrial Registration Form March 2025

(MS Word Document - 363.6 KB)

Registry-Based Studies Capacity and Capability Assessment Form (March 2025)

(MS Word Document - 326.8 KB)

Equipment Funding Expression of Interest Form (July 2025)

(MS Word Document - 325.6 KB)

Guidelines

Applicant user guide to ERM

(PDF File - 9.5 MB)

Create a Human Research Ethics Application (HREA) in ERM

(PDF File - 352.7 KB)

Creating SSAs for sites - by HREA owner

(PDF File - 264.0 KB)

Creating SSAs for sites - SSA owner

(PDF File - 400.6 KB)

Electronic Signatures and Clinical Trial Research Agreement execution in Australia

This paper provides guiding principles to optimise digital technology for executing CTRAs using eSignatures. (PDF File - 236.3 KB)

Guidance on Scientific Expert Review Toolkit

This document provides background information and guidance for a scientific expert reviewer to conduct scientific review, at the request of an ethics committee in Victoria, regarding early phase clinical trials. (PDF File - 2.5 MB)

HRECs, RGOs and Organisations

This document provides details and contact information for organisations taking part in the National Mutual Acceptance (NMA) initiative. (PDF File - 352.7 KB)

How to upload documents in ERM

(PDF File - 415.5 KB)

Jurisdictional Legislative Requirements

This document aims to provide an overview of the various legislative and administrative frameworks that currently exist in Commonwealth, States and Territories and apply to the approval of human research under Mutual Acceptance of Ethics and Scientific Review. This document is not a substitute for legal advice. (PDF File - 334.6 KB)

Monitoring and Reporting Matrix

This matrix is designed to assist investigators, HREC Coordinators and Research Governance Officers. It provides information on reporting requirements for multi-centre human research projects taking place in Australia. (MS Excel Document - 437.9 KB)

National Mutual Acceptance (NMA) Ethics and Governance Matrix

Arrangements for ethics and research governance/Site Specific Assessment (SSA) applications across the NMA jurisdictions are described in this NMA Ethics and Governance Matrix table. (PDF File - 187.8 KB)

(PDF File - 247.5 KB)

(PDF File - 230.9 KB)

NMA Standard Principles for Operation

(PDF File - 613.0 KB)

NMA Data Linkage Guide

The National Mutual Acceptance (NMA) scheme has been revised to better support researchers undertaking multi-jurisdiction studies involving linkage of data. (MS Word Document - 156.1 KB)

NMA ethics application: Projects with a Western Australia site

Additional supporting documents that address state legislation e.g. Western Australian Specific Module (WASM) and Victorian Specific Module (VSM) may be required for some research projects. (MS Word Document - 140.2 KB)

Post approval and Post authorisation subforms in ERM

(PDF File - 254.6 KB)

Roles and Responsibilities in a Research Project

(MS Word Document - 140.6 KB)

Research governance and Site specific assessment - Process and practice (Appendices)

(MS Word Document - 580.1 KB)

Research governance and Site specific assessment - Process and practice

The purpose of this document is to provide guidance to assist all sectors involved in clinical trials to understand the processes used to meet the regulatory requirements for clinical trial research in Australia. (PDF File - 1.1 MB)

Signature requests and submission in ERM

(PDF File - 340.5 KB)

Victorian Hospital Research Office – Contact details

(MS Word Document - 149.6 KB)

Victorian Specific Module Guidelines

These guidelines provide useful information and specific instructions for completing Sections 1, 2 and 3 of the Victorian Specific Module. (PDF File - 351.8 KB)

Victorian Specific Module (VSM) in ERM

For each research project that utilises the Human Research Ethics Application (HREA) form and has a site in Victoria, the Victorian Specific Module (VSM) must be completed and submitted to the reviewing Human Research Ethics Committee (HREC) as part of the ethics application. (PDF File - 424.7 KB)

Statutory Guidelines on Research

(PDF File - 217.3 KB)

Use of Ionising Radiation-flow diagram

(PDF File - 148.1 KB)

Laws relating to the provision of consent for persons that do not have decision-making capacity to participate in research.pdf

(PDF File - 203.3 KB)

ATP Teletrial Support Program-ATP-VIC Supplementary Information (February 2026)

(PDF File - 440.6 KB)

REDCap, TSP process summary and PICFs_April 2024

(PDF File - 269.7 KB)

Teletrial Support Program Guidelines

(PDF File - 360.3 KB)

ATP-VIC Supplementary Information-Addendum (March 2025)

(PDF File - 274.6 KB)

Teletrial Equipment Funding Initiative (February 2026)

(PDF File - 174.2 KB)

Guide for Setting up Teletrials May 2025

(PDF File - 658.9 KB)

Templates

Clinical Trial Research Agreement

For an Investigator Initiated Study (MS Word Document - 53.2 KB)

Clinical Trial Research Agreement (CTRA) Teletrial subcontract

(MS Word Document - 52.5 KB)

HREC Radiation Notification Letter

Template letter to use if Ionising radiation exposure in a research project is not considered to be additional to normal clinical management/care at the site and the reviewing HREC is in Victoria (MS Word Document - 21.0 KB)

Contact List Template

(MS Excel Document - 11.6 KB)

Stand Alone Teletrial PICF

The Stand Alone Teletrial PICF is used for an approved trial when a teletrial will be added to the existing trial, instead of amending a Master PICF. This is used for the added Satellite Site(s). (MS Word Document - 48.0 KB)

Stand Alone Teletrial PICF for Person Responsible\Medical treatment decision maker

(MS Word Document - 45.3 KB)

CTRA for Investigator-Initiated Teletrials

(MS Word Document - 113.4 KB)